510(k) · Cleared
ClearedDentMix VPS Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Product Brands, Inc. · ELW Material, Impression
Cleared on Apr 27, 2023 as substantially equivalent to K151150 (Pac-Dent International, Inc., 2015) after a 120-day review. Its family tree reaches back 2 generations to 2009. 2 later devices descend from it.
- Decided
- Apr 27, 2023
- Review
- 120 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K091613 (2009). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK091613 TAKE 1Kerr Corp. · 2009
- 1 generation backK151150 ElementsPac-Dent International, Inc. · 2015
- This deviceK223892 DentMix VPS Impression MaterialInnovative Product Brands, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK254152 Dia-X Sil Light BodyDiaDent Group International · 2026
- Descendant · cites it directly · 0 of its ownK254142 Dia-X Sil Heavy BodyDiaDent Group International · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091613 | TAKE 1 | Kerr Corp. | 2009 | — |
| −1 | K151150 | Elements | Pac-Dent International, Inc. | 2015 | — |
| 0 (this device) | K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | 2023 | — |
| +1 | K254152 | Dia-X Sil Light Body | DiaDent Group International | 2026 | — |
| +1 | K254142 | Dia-X Sil Heavy Body | DiaDent Group International | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151150 | ElementsSummary page 5…cteristics Descriptive Subject Device Predicate Device Summary Information DentMix VPS Impression Elements (K151150) Material (K223892) Indications for DentMix VPS Impression ElementsTM is intended for use… | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K254152 (DiaDent Group International, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223892 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223892: DentMix VPS Impression Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223892
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026